Genzyme Announces Results of Phase 3 Trial of Clolar in Adult AML
October 20 2010 - 10:32AM
Business Wire
Genzyme Corporation (Nasdaq: GENZ) announced results today from
its CLASSIC I phase 3 trial comparing Clolar® (clofarabine) in
combination with the chemotherapy agent cytarabine (ara-c) to
cytarabine plus placebo in relapsed-refractory adult acute myeloid
leukemia (AML). Although the study did not show a difference
between the arms in the primary endpoint of overall survival, the
Clolar combination demonstrated statistical significance across all
four pre-specified secondary efficacy endpoints: overall remission
rate; complete remission rate; event-free survival; and four-month
event free survival.
“Of importance, the Clolar combination doubled the overall
remission rate to 47 percent,” said Hagop Kantarjian, M.D., MD
Anderson Cancer Center. “Also, we see a 37 percent improvement in
event-free survival, a particularly important measure of clinical
benefit.”
Preliminary review of adverse events revealed no new safety
signals.
“We remain committed to the development of Clolar in adult acute
myeloid leukemia,” said Mark Enyedy, Genzyme President of
Transplant, Oncology, and Multiple Sclerosis. “We are collaborating
with the United Kingdom’s National Cancer Research Institute on a
large randomized clinical trial in front-line adult AML.” Data from
this study is anticipated in 2011.
The CLASSIC I study was a randomized, double-blind,
placebo-controlled clinical trial that compared Clolar in
combination with cytarabine to cytarabine plus placebo in patients
55 years and older with AML who relapsed or were refractory after
receiving up to two prior induction regimens. The combination of
Clolar with cytarabine was developed by Stefan Faderl, M.D. and
colleagues at the MD Anderson Cancer Center. Dr. Faderl served as
the principal investigator of CLASSIC I, which enrolled 326
patients in North America and Europe. The event driven trial was
powered to detect at least a 50 percent improvement in overall
median survival in the Clolar plus cytarabine combination arm.
The CLASSIC I study results will be submitted to an upcoming
medical meeting and discussed with regulatory authorities.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is
dedicated to making a major positive impact on the lives of people
with serious diseases. Since 1981, the company has grown from a
small start-up to a diversified enterprise with approximately
10,000 employees in locations spanning the globe and 2009 revenues
of $4.5 billion. In 2010, Genzyme was named to the Fortune 500.
With many established products and services helping patients in
100 countries, Genzyme is a leader in the effort to develop and
apply the most advanced technologies in the life sciences. The
company's products and services are focused on rare inherited
disorders, kidney disease, orthopaedics, cancer, transplant, and
immune disease. Genzyme's commitment to innovation continues today
with a substantial development program focused on these fields, as
well as cardiovascular disease, neurodegenerative diseases, and
other areas of unmet medical need.
This press release contains forward-looking statements regarding
Genzyme’s future plans and business strategies, including its
expectations about the timing of results from the front-line adult
AML clinical trial and anticipated discussions with regulatory
authorities about the CLASSIC I study results. These statements are
subject to risks and uncertainties that could cause actual results
to differ materially from those projected in these forward-looking
statements, including the outcome and timing of the front-line
adult AML trial, the timing and outcome of discussions with
regulatory agencies regarding Clolar, the actual safety and
efficacy of Clolar for the indications in which it is being tested
and the risks and uncertainties described in reports filed by
Genzyme with the Securities and Exchange Commission under the
Securities Exchange Act of 1934, as amended, including without
limitation the information under the heading “Risk Factors” in
Genzyme’s Quarterly Report on Form 10-Q for the quarter ending June
30, 2010. Genzyme cautions investors not to place substantial
reliance on the forward-looking statements contained in this press
release. These statements speak only as of the date of this press
release, and Genzyme undertakes no obligation to update or revise
these statements.
Genzyme® and Clolar® are registered trademarks of Genzyme
Corporation or its subsidiaries. All rights reserved.
Genzyme’s press releases and other company information are
available at www.genzyme.com and by calling Genzyme’s investor
information line at 1-800-905-4369 within the United States or
1-678-999-4572 outside the United States.
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